Keryx says Auryxia shortage 'imminent'

The company has announced that their phosphate binder Auryxia will not be available until Q4. 

By Nicole Gray • Aug. 4, 2016

Takeda hones R&D focus in $725 million restructuring

The company plans to build out three R&D hubs in the U.S. and Japan, aimed at underpinning a more global approach to partnering and collaboration. 

By Edwin Lopez • July 29, 2016

Teva will provide long-term API contracts to producers in 15 markets

U.S. regulators set the condition to ensure Teva does not use API supply contracts to force competitors to raise product prices.

By Edwin Lopez • July 28, 2016

GSK to invest $360 million in UK plants despite Brexit vote

The spending might help ease concerns about Britain's future as a pharma hub.

By Randy Lilleston • July 28, 2016

Shnaghai Fosun to buy large stake in Gland Pharma for $1.4 billion

This acquisition represents the first major purchase of an Indian manufacturing outfit by a Chinese firm. 

By Nicole Gray • July 28, 2016

EU regulator recommends market suspension for dozens of generics

The European Medicines Agency concluded bioequivalence studies conducted by an India-based contract researcher to support generic approvals were "flawed." 

By Edwin Lopez • July 25, 2016

Pfizer presses on with expansion of Irish manufacturing site

When completed, the build-out is expected to add up to 350 jobs at the Grange Castle site, according to a new report. 

By Nicole Gray • July 21, 2016

Merck KGaA building $115 million life science facility in MA

The new MiliporeSigma facility will house the M Lab Collaboration Center, one of nine such hubs planned for construction worldwide. 

By Nicole Gray • July 21, 2016

Glaxo failed to resolve contamination at UK plant, FDA says

The FDA "strongly urged" Glaxo to dedicate the site to only penicillin production in light of repeated contamination problems. 

By Edwin Lopez • July 20, 2016

Cipla invests $90 million in South African biosim plant

Only 2% of patients in Africa have access to biologics, according to the Indian drugmaker. 

By Nicole Gray • July 14, 2016

GE Healthcare ventures into cell therapy supply space

Eyeing a potential $1 billion opportunity, General Electric's health unit just snapped up a Switzerland-based cell bioprocessing systems supplier. 

By Edwin Lopez • July 14, 2016

Drug manufacturer Patheon plans major IPO to pay down debt

The company expects to list 30.5 million shares on the New York Stock Exchange. 

By Nicole Gray • July 11, 2016

Pfizer planning expansion of Irish manufacturing facility

The planned move would further expand Pfizer's presence in Ireland, even after its failed relocation attempt. 

By Nicole Gray • July 7, 2016

3-D drug firm Aprecia wins another $30 million in venture-funded debt

Aprecia aims to advance its pipeline and commercialize Spritam, the first 3-D drug approved by the FDA.

By Nicole Gray • July 7, 2016

Five NCI cell therapy studies resume production after April halt

Lion Biotechnologies' three affiliated studies were resumed, but Kite's four studies remain suspended.

By Edwin Lopez • July 7, 2016

With insulin market set for shake-up, Novo Nordisk expands production plant

The Danish company will invest nearly $60 million in its large Kalundborg facility. 

By Nicole Gray • July 5, 2016

InVentiv Health comes on board as Pfizer's fourth CRO

Pfizer's other three preferred-provider contract research organizations are Icon, Parexel and PPD. 

By Nicole Gray • June 30, 2016

Icagen to buy Sanofi lab, widening R&D reach

As part of the deal, Icagen will also manage the site's "extensive" library of drug compounds. 

By Nicole Gray • June 30, 2016

Pfizer to open first Asia biotech center in China

Located in Hangzhou, the $350 million facility will eventually produce biosimilar drugs for both Chinese and global markets. 

By Ned Pagliarulo • June 28, 2016

Pfizer plans to close Colorado production facility

Acquired when Pfizer bought Hospira last year, the site currently employs around 100 people. 

By Ned Pagliarulo • June 23, 2016

India targets drugmakers with wave of inspections

At the same time, the Indian government is planning a 'comprehensive review' of existing drug laws, aiming to improve standards and the business environment. 

By Ned Pagliarulo, Nicole Gray • June 23, 2016

Opko wins approval for kidney drug after manufacturing snag

The FDA had turned down Opko's original application due to manufacturing issues at third-party contractor Catalent. 

By Nicole Gray • June 23, 2016

Kite Pharma opens cell therapy plant as lead CAR-T candidate gathers steam

The company expects a 2017 commercial launch for its flagship CAR-T therapy, which is currently in testing for several types of blood cancer. 

By Nicole Gray, Ned Pagliarulo • June 21, 2016

DIA Booth #617 - ICON

Manufacturers are being forced to generate more complex and comprehensive bodies of real world evidence about drugs’ effectiveness and value.

By Ramita Tandon, Executive Vice President
 Commercialisation & Outcomes, ICON plc • June 16, 2016

Pfizer begins construction on $200 million biologics plant in MA

When completed, the facility will produce complex biologics and vaccines—a rapidly growing part of Pfizer's business. 

By Ned Pagliarulo • June 16, 2016